Metal Ion Concentration Between Coated and Uncoated TKA

Technische Universität Dresden

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Device: Standard Total Knee Arthroplasty; Device: Coated Total Knee Arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03047564

TKAcoated

Details and patient eligibility

About

Metal ion release from metal implants may have side effects. It can be reduced by coating of the implant. This study compares coated and uncoated TKA.

Full description

Patients are randomized to receive a coated or uncoated TKA. Patients are assessed before surgery, after 3 month, 1 year and 5 years.

Blood samples are collected in 7.5 ml S-Monovette® tubes (for trace metal analysis, Sarstedt AG, Germany) using a specific steel needle for trace metal analysis (Sarstedt AG, Germany). Within one hour, plasma was separated by centrifugation at 2500g for ten minutes. Samples were stored at -20°C before being analysed for chromium, cobalt, molybdenum and nickel content using a graphite furnace atomic absorption spectrometer Z-8270 with Polarisation-Zeeman-Absorption (Hitachi Ltd., Japan). The accuracy and precision of the method is validated to < 10% using the control materials SeronormTM Trace Elements Serum (SERO AS, Norway). The detection limit of the method is estimated at 0.5µg/l for chromium, cobalt and molybdenum, 1.0µg/l for nickel (mean + 3 standard deviations from buffer). All probes having ion levels below the detection limit were adjusted to 0.25µg/l for chromium, cobalt and molybdenum and 0.5µg/l for nickel.

Clinical outcome is measured with the Knee Society Score, Oxford Knee Score, Short-Form 36 and University of Los Angeles Activity Score.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• indication to TKA
• no other metal implant

Exclusion criteria

• no informed consent
• not able to understand study and/or questionnaires
• Need of a higher constrained implant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Coated Total Knee Arthroplasty

Experimental group

Description:

Implantation of a coated Total Knee Arthroplasty

Treatment:

Device: Coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

Active Comparator group

Description:

Implantation of a Standard Total Knee Arthroplasty

Treatment:

Device: Standard Total Knee Arthroplasty